News from Tuesday, August 5, 2025
Articles
Real-World Evidence and AI: Q&A with ISPOR’s Mitch Higashi
(8/5, Christiane Truelove, Med Ad News) reports “...[Higashi:] In the long term (3-5 years), there is a real possibility that quantum computing will have disruptive impact on RWE. Exponentially faster and more complex analysis of high-dimensionality real-world data, has the potential to move HEOR into the realm of discovering treatment effects, identifying more accurate patient stratification for regulatory purposes, and developing more complex modeling scenarios to forecast the impact of new treatments beyond the trial setting. The transition from a binary mindset of ones and zeros – where patients either have the disease or they don’t – to a world where patients may exist in a spectrum of disease states with probabilistic outcomes – will require a radical rethinking of what we have been taught and test the strength of our beliefs.” Full
Redefining Clinical Trials: How Real-World Data Integration and Agentic AI Are Turbocharging Pharma Research
(8/5, Joseph Paxton, PharmaLive) comments “...Today, agentic AI-enabled platforms can train models to correlate subtle post-operative vitals with self-reported symptoms, and then recommend action steps backed by peer-reviewed literature and real-world outcomes. This goes beyond simple automation, incorporating AI that thinks, prioritizes, and acts alongside clinicians and researchers. Because this intelligence layer is built using cloud-native tools — like Apache Beam for stream processing, Databricks for analytics, and NLP engines for refining unstructured data — it remains elastic, scalable, and fully compliant with regulatory standards like HIPAA. For clinical trials, the implications are transformative.” Full
Losing Public Health Data: What’s at Risk with Aaron Carroll
(8/4, Aima Ali, AcademyHealth Blog) comments “...Dr. Carroll explains the importance of federal health data infrastructure. ‘So many people's work depends on data that are timely, accessible and comparable across regions and populations. And without it, they can't do basic things like identify gaps in care, track the success of interventions, or evaluate whether policy changes are helping or harming people. So we got teaching, mentoring, grant writing, publishing, caring for people, all of that build on the foundation of evidence,’ Dr. Caroll said.” Full
Trump Says Pharma, Chips Tariffs Coming in 'Next Week or So'
(8/5, Michael Shepard, Bloomberg) reports “...President Donald Trump said that US tariffs on semiconductor and pharmaceutical imports would be announced ‘within the next week or so,’ as the administration prepares to target key economic sectors in its effort to remake global trade. ‘We'll be putting a initially small tariff on pharmaceuticals, but in one year - one and a half years, maximum - it's going to go to 150% and then it's going to go to 250% because we want pharmaceuticals made in our country,’ Trump said Tuesday in an interview on CNBC.” Subscription Required
Journals
Health Technology Assessment, Again: A Transparent, Evidence-Based Approach For CMS Drug Price Negotiations
Daniel A. Ollendorf, Leah Z. Rand, Alessandra Blonda, Helen Mooney, Marie Phillips, and Anirban Basu
August 2025, Health Affairs
Fee-For-Service, Accountable Care Organizations, And Medicare Advantage: Why?
Michael E. Chernew
August 2025, Health Affairs
Real-World Comparative Effectiveness of Biologic Therapies in Severe Asthma: EU-ADVANTAGE
Giorgio Walter Canonica, et al.
August 4, 2025, ERJ Open Research
Comparable Efficacy of Generic and Original Alginate for Symptom Control in PPI-Refractory GERD
Kawin Tangvoraphonkchai, et al.
August 4, 2025, Scientific Reports
APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety
Katsiaryna Bykov, PharmD, ScD, et al.
August 5, 2025, Value in Health